Efficacy and Safety of Azilsartan Compared to Olmesartan Medoxomil in Chinese Participants With Grade I or II Essential Hypertension

Hengrui Medicine

Status and phase

Unknown

Phase 3

Conditions

Essential Hypertension

Treatments

Drug: Olmesartan medoxomil

Drug: azilsartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT02407210

HR-AQST-2014

Details and patient eligibility

About

To investigate the efficacy and safety of azilsartan compared to olmesartan medoxomil in patients with grade I or II essential hypertension

Enrollment

304 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Both sexes. eighteen years or older and no more than 70 years at the time of informed consent
Grade I or II essential hypertension
Both sitting systolic and diastolic blood pressures at Week 0 during the run-in period meet the following criteria:

Sitting systolic blood pressure: greater than or equal to 150 mmHg and less than 180 mmHg

Sitting diastolic blood pressure: greater than or equal to 95 mmHg and less than 110 mmHg
Able to understand the content of the study and comply with the study and to give informed consent in writing before participating in the study

Exclusion criteria

Secondary hypertension, grade III hypertension (sitting systolic blood pressure greater than or equal to 180 mmHg or sitting diastolic blood pressure greater than or equal to 110 mmHg), or malignant hypertension，hypertensive emergencies，hypertensive urgencies
The following circulatory-related diseases or symptoms:

(1) Cardiac disease: angina pectoris; valvular stenosis; atrial fibrillation; the following diseases requiring medication: congestive heart failure or arrhythmia； (2) Cerebrovascular disorder: cerebral infarction, cerebral hemorrhage (onset within 24 weeks before start of the screening period), transient ischemic attack (onset of an attack within 24 weeks before start of the screening period)； (3) Vascular disease: arteriosclerosis obliterans with symptoms of intermittent claudication； (4) Progressive hypertensive retinopathy: hemorrhage, exudation, or papilledema (observed within 24 weeks after start of the screening period)

Decrease in sitting diastolic blood pressure by 8 mmHg or more at the end of the run-in period (Week 0) compared to the start of the screening period
Day/night reversal, e.g., nightshift worker
Unilateral or bilateral renal artery stenosis
Clinically apparent hepatic and renal impairment (e.g., with AST and ALT values of 2.5 x upper limit of normal or higher, with serum creatinine value of 1.5 x upper limit of normal or higher during the screening period)
Hyperkalemia (with a laboratory value of 5.5 mEq/L or higher during the run-in period)
Malignant tumor
Compliance with the study drug of less than 80% during the run-in period
Poorly-controlled diabetes mellitus (fasting plasma glucose greater than 11mmol/L)，and/or complications (kidney disease, peripheral neuropathy) at Screening.
History of hypersensitivity or allergy to olmesartan medoxomil tablets and related drugs (ARB, ACE inhibitors, and renin inhibitors)
History of drug abuse (defined as illegal drug use) or alcohol dependency within 2 years before start of the screening period
Requirement of the excluded treatment
Pregnant or lactating women
Participation in another clinical trial or post-marketing clinical trial within 30 days before start of the screening period
Dangerous machinery operator such as aerial worker，motor vehicle driver